Anavex Life Sciences Corp (AVXL)

[Jonjones325]

It seems that our PDD data will/should be included in our MAA. The genetic data which has our patients returning to a more healthy state should be eye opening.

Our cumulative data is quite powerful and this current landscape makes it that much more appealing.

Yes, data from other relevant trials can be used to support a Marketing Authorization Application (MAA) submitted to the European Medicines Agency (EMA). These additional data can include results from previous clinical trials, pharmacovigilance data, real-world evidence, and other studies that provide relevant information about the safety, efficacy, and quality of the medicinal product.

When including data from other trials in an MAA, it's essential to ensure that the trials are adequately designed, conducted, and documented to meet the regulatory standards set by the EMA. The data should be relevant to the indication and patient population for which the marketing authorization is sought, and they should be appropriately analyzed and presented to support the application.

EMA evaluates all submitted data as part of the MAA review process to assess the benefit-risk profile of the medicinal product and determine whether it meets the necessary regulatory requirements for approval. Including data from other trials can provide additional evidence to support the overall assessment of the product's safety, efficacy, and quality.